Https Www.parkland.edu Portals 3 Global Documents Catalog-pos Mathematics.pdf
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Documents
This page contains final documents only for both IMDRF and GHTF.
- IMDRF documents
- GHTF final documents
IMDRF documents
In this section: Technical documents | Procedural documents | Information documents | Outcome statements
| IMDRF code | Document title | Date posted | Pages |
|---|---|---|---|
| IMDRF/MDSAP WG/N4FINAL:2021 (Edition 2) | Competence and Training Requirements for Auditing Organizations - PDF (712kb) Competence and Training Requirements for Auditing Organizations - DOC (131kb) | 20 October 2021 | 24 |
| IMDRF/MDSAP WG/N6FINAL:2021 (Edition 2) | Regulatory Authority Assessor Competence and Training Requirements - PDF (560kb) Regulatory Authority Assessor Competence and Training Requirements - DOCX (114kb) | 20 October 2021 | 18 |
| IMDRF/MDSAP WG/N11FINAL:2021 (Edition 2) | MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (1Mb) MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - DOCX (432kb) | 20 October 2021 | 37 |
| IMDRF/GRRP WG/N66FINAL:2021 | Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews - PDF (1.2Mb) Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews - DOCX (407kb) | 1 July 2021 | 34 |
| IMDRF/MDCE WG/N65FINAL:2021 (formerly GHTF/SG5/N4:2010) | Post-Market Clinical Follow-Up Studies - PDF (132kb) Post-Market Clinical Follow-Up Studies - DOC (451kb) | 20 May 2021 | 17 |
| IMDRF/AE WG/N43FINAL:2021 Updated Annexes (Edition 5.0) | Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Problem - XLSX (51kb) Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Problem - JSON (160kb) Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Type of Investigation - XLSX (13kb) Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Type of Investigation - JSON (13kb) Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Findings - XLSX (24kb) Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Findings - JSON (49kb) Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Conclusion - XLSX (15kb) Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Conclusion - JSON (15kb) Annex E: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Clinical Signs and Symptoms or Conditions - XLSX (160kb) Annex E: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Clinical Signs and Symptoms or Conditions - JSON (315kb) Annex F: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Health Impact - XLSX (16kb) Annex F: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Health Impact - JSON (20kb) Annex G: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Component - XLSX (33kb) Annex G: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Component - JSON (85kb) Appendix B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Change Log - XLSX (46kb) Release Notes: IMDRF terminologies for categorized Adverse Event Reporting (AER) - TXT (2kb) | 2 March 2021 | - |
| IMDRF/IVD WG/N64FINAL:2021 (formerly GHTF/SG1/N045:2008) | Principles of In Vitro Diagnostic (IVD) Medical Devices Classification - PDF (213kb) Principles of In Vitro Diagnostic (IVD) Medical Devices Classification - DOCX (120kb) | 21 May 2021 | 16 |
| IMDRF/GRRP WG/N63FINAL:2020 | Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (370kb) Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - DOCX (113kb) | 25 September 2020 | 21 |
| IMDRF/GRRP WG/N61FINAL:2020 | Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (785kb) Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - DOCX (243kb) | 25 September 2020 | 69 |
| IMDRF/AE WG/N43FINAL:2020 (Edition 4) | Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes - PDF (1.21Mb) Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes - DOCX (280kb) | 20 April 2020 | 23 |
| IMDRF/CYBER WG/N60FINAL:2020 | Principles and Practices for Medical Device Cybersecurity - PDF (951kb) Principles and Practices for Medical Device Cybersecurity - DOCX (407kb) | 20 April 2020 | 46 |
| IMDRF/GRRP WG/N59FINAL:2020 | Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (730kb) Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - DOCX (123kb) | 20 April 2020 | 26 |
| IMDRF/PMD WG/N58FINAL:2020 | Personalized Medical Devices - Regulatory Pathways - PDF (612kb) Personalized Medical Devices - Regulatory Pathways - DOCX (4.15Mb) | 20 April 2020 | 22 |
| IMDRF MDCE WG/N57FINAL:2019 (formerly GHTF/SG5/N3:2010) | Clinical Investigation - PDF (267kb) Clinical Investigation - DOCX (152kb) | 10 October 2019 | 11 |
| IMDRF MDCE WG/N56FINAL:2019 (formerly GHTF/SG5/N2R8:2007) | Clinical Evaluation - PDF (322kb) Clinical Evaluation - DOCX (249kb) | 10 October 2019 | 30 |
| IMDRF MDCE WG/N55FINAL:2019 (formerly GHTF/SG5/N1R8:2007) | Clinical Evidence - Key Definitions and Concepts - PDF (185kb) Clinical Evidence - Key Definitions and Concepts - DOCX (133kb) | 10 October 2019 | 8 |
| IMDRF/GRRP WG/N52FINAL:2019 | Principles of Labelling for Medical Devices and IVD Medical Devices - PDF (763kb) Principles of Labelling for Medical Devices and IVD Medical Devices - DOCX (143kb) | 21 March 2019 | 28 |
| IMDRF/UDI WG/N48FINAL:2019 | Unique Device Identification system (UDI system) Application Guide - PDF (3.53Mb) Unique Device Identification system (UDI system) Application Guide - DOCX (12.5Mb) | 21 March 2019 | 68 |
| IMDRF/RPS WG/N9FINAL:2019 (Edition 3) | Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC) - PDF (2.04Mb) Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC) - DOCX (350kb) | 21 March 2019 | 53 |
| IMDRF/RPS WG/N13FINAL:2019 (Edition 3) | In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) - PDF (1.86Mb) In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) - DOCX (369kb) | 21 March 2019 | 54 |
| IMDRF/RPS WG/N27FINAL:2019 | Assembly and Technical Guide for IMDRF Table of Contents Submissions - PDF (886kb) Assembly and Technical Guide for IMDRF Table of Contents Submissions - DOCX (150kb) IVD Template - ZIP (43KB) nIVD Template - ZIP (41kb) | 20 March 2019 | 20 |
| IMDRF/Standards WG/N51FINAL:2018 | Optimizing Standards for Regulatory Use - PDF (769kb) Optimizing Standards for Regulatory Use - DOCX (1.74Mb) | 12 November 2018 | 24 |
| IMDRF/GRRP WG/N47FINAL:2018 | Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - PDF (260kb) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - DOCX (160kb) | 7 November 2018 | 37 |
| IMDRF/PMD WG/N49FINAL:2018 | Definitions for Personalized Medical Devices - PDF (165kb) Definitions for Personalized Medical Devices - DOCX (111kb) | 7 November 2018 | 10 |
| IMDRF/Registry WG/N46FINAL:2018 | Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making - PDF (479kb) Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making - DOCX (147kb) | 27 March 2018 | 17 |
| IMDRF/NCAR WG/N14FINAL:2017 (Edition 2) | Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form - PDF (734kb) Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form - DOCX (139kb) | 21 September 2017 | 18 |
| IMDRF/SaMD WG/N41FINAL:2017 | Software as a Medical Device (SaMD): Clinical Evaluation - PDF (1.10Mb) Software as a Medical Device (SaMD): Clinical Evaluation - DOCX (1.13Mb) | 21 September 2017 | 30 |
| IMDRF/GRRP WG/N40FINAL:2017 | Competence, Training, and Conduct Requirements for Regulatory Reviewers - PDF (174kb) Competence, Training, and Conduct Requirements for Regulatory Reviewers - DOCX (112kb) | 16 March 2017 | 19 |
| IMDRF/Registry WG/N42FINAL:2017 | Methodological Principles in the Use of International Medical Device Registry Data - PDF (660kb) Methodological Principles in the Use of International Medical Device Registry Data - DOCX (827kb) | 16 March 2017 | 27 |
| IMDRF/REGISTRY WG/N33FINAL:2016 | Principles of International System of Registries Linked to Other Data Sources and Tools - PDF (873kb) Principles of International System of Registries Linked to Other Data Sources and Tools - DOCX (203kb) | 30 September 2016 | 28 |
| IMDRF/MDSAP WG/N3FINAL:2016 (Edition 2) | Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (621kb) Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - DOCX (173kb) | 24 March 2016 | 30 |
| IMDRF/RPS WG/N19FINAL:2016 | Common Data Elements for Medical Device Identification - PDF (747kb) Common Data Elements for Medical Device Identification - DOCX (135kb) | 24 March 2016 | 17 |
| IMDRF/MDSAP WG/N24FINAL:2015 | Medical Device Regulatory Audit Reports - PDF (154kb) Medical Device Regulatory Audit Reports - DOCX (80kb) | 2 October 2015 | 17 |
| IMDRF/SaMD WG/N23FINAL:2015 | Software as a Medical Device (SaMD): Application of Quality Management System - PDF (364kb) Software as a Medical Device (SaMD): Application of Quality Management System - DOCX (749kb) | 2 October 2015 | 34 |
| IMDRF/NCAR WG/N14FINAL:2015 See also Edition 2 | Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form - PDF (195) Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form - DOC (133) | 26 March 2015 | 18 |
| IMDRF/SaMD WG/N12FINAL:2014 | Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb) Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations - DOCX (176kb) | 18 September 2014 | 30 |
| IMDRF/MDSAP WG/N3FINAL:2013 See also Edition 2 | Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (244kb) Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - DOCX (133kb) | 18 December 2013 | 24 |
| IMDRF/UDI WG/N7FINAL:2013 | UDI Guidance: Unique Device Identification (UDI) of Medical Devices - PDF (324kb) UDI Guidance: Unique Device Identification (UDI) of Medical Devices - DOCX (130kb) | 18 December 2013 | 19 |
| IMDRF/SaMD WG/N10FINAL:2013 | Software as a Medical Device (SaMD): Key Definitions - PDF (119kb) Software as a Medical Device (SaMD): Key Definitions - DOCX (68kb) | 18 December 2013 | 9 |
| IMDRF code | Document title | Date posted | Pages |
|---|---|---|---|
| IMDRF/MC/N2 FINAL:2021 (Edition 7) | IMDRF Standard Operating Procedures - PDF (416kb) IMDRF Standard Operating Procedures - DOCX (277kb) | 21 May 2021 | 35 |
| IMDRF/MC/N1 FINAL:2018 (Edition 4) | IMDRF Terms of Reference - PDF (208kb) IMDRF Terms of Reference - DOCX (96kb) | 27 July 2018 | 8 |
| IMDRF/MC/N2 FINAL:2017 (Edition 4) | IMDRF Membership Application Form - DOCX (123kb) | 27 November 2017 | 27 |
| IMDRF/MC/N39 FINAL:2020 (Edition 2) | IMDRF Strategic Plan 2021-2025 - PDF (496kb) IMDRF Strategic Plan 2021-2025 - DOCX (177kb) | 25 September 2020 | 16 |
| IMDRF/MC/N16 FINAL:2014 | IMDRF Document Format and Style Guide - PDF (75kb) IMDRF Document Format and Style Guide - DOCX (79kb) | 23 April 2014 | 14 |
| IMDRF/MC/N17 FINAL:2014 | IMDRF Document Template - DOCX (44kb) | 23 April 2014 | 6 |
| IMDRF/MC/N18 FINAL:2014 | IMDRF Presentation Template - PPT (116kb) | 23 April 2014 | 3 |
| IMDRF code | Document title | Date posted | Pages |
|---|---|---|---|
| IMDRF/AE WG/N44FINAL:2020 (Edition 3) | Maintenance of IMDRF AE Terminologies - PDF (384kb) Maintenance of IMDRF AE Terminologies - DOCX (56kb) Appendices A & B: Change Request Form and Change Log - XLSX (19kb) | 20 April 2020 | 7 |
| IMDRF/UDI WG/N54FINAL:2019 | System requirements related to use of UDI in healthcare including selected use cases - PDF (306kb) System requirements related to use of UDI in healthcare including selected use cases - DOCX (10.1Mb) | 21 March 2019 | 11 |
| IMDRF/UDI WG/N53FINAL:2019 | Use of UDI Data Elements across different IMDRF Jurisdictions - PDF (86kb) Use of UDI Data Elements across different IMDRF Jurisdictions - DOC (71kb) Annex - Use of UDI Data Elements across different IMDRF Jurisdictions - XLSX (391kb) | 21 March 2019 | 5 |
| IMDRF RPS Communication - 24 January 2019 | IMDRF RPS Communication - 24 January 2019 - PDF (72KB) IMDRF RPS Communication - 24 January 2019 - DOCX (46KB) | 4 April 2019 | 2 |
| IMDRF/RPS WG/N50FINAL:2018 | Round 2, RPS Beta Testing Report - PDF (694kb) Round 2, RPS Beta Testing Report - DOCX (387kb) | 27 July 2018 | 88 |
| IMDRF RPS WG/N45FINAL:2017 | Data Exchange Guidelines - Common Data Elements for Medical Device Identification - PDF (1084kb) Data Exchange Guidelines - Common Data Elements for Medical Device Identification - DOCX (707kb) | 16 March 2017 | 123 |
| IMDRF/MDSAP WG/N29FINAL:2015 | Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes - PDF (41Kb) Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes - DOCX (47Kb) | 2 October 2015 | 2 |
| IMDRF/NCAR WG/N30FINAL:2015 | Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan - PDF (103Kb) Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan - DOCX (62Kb) | 2 October 2015 | 7 |
| IMDRF/NCAR WG/N31FINAL:2015 | Medical Devices: Post Market Surveillance: National Competent Authority Report (NCAR) Pilot Plan; Implementing Material - PDF (562Kb) | 2 October 2015 | 43 |
| IMDRF/RPS WG/N32FINAL:2015 | Strategic Assessment of Electronic Submission Messaging Formats - PDF (242Kb) Strategic Assessment of Electronic Submission Messaging Formats - DOCX (125Kb) | 2 October 2015 | 36 |
| IMDRF/MC/N34 FINAL:2015 | Statement regarding Use of ISO 14971:2007 "Medical devices - Application of risk management to medical devices" - PDF (55Kb) Statement regarding Use of ISO 14971:2007 "Medical devices - Application of risk management to medical devices" - DOCX (56Kb) | 2 October 2015 | 3 |
| IMDRF/MC/N35 FINAL:2015 | Statement regarding Use of IEC 62304:2006 "Medical device software - Software life cycle processes" - PDF (55Kb) Statement regarding Use of IEC 62304:2006 "Medical device software - Software life cycle processes" - DOCX (53Kb) | 2 October 2015 | 3 |
| IMDRF/MC/N36 FINAL:2015 | Statement regarding Use of IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" - PDF (35Kb) Statement regarding Use of IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" - DOCX (58Kb) | 2 October 2015 | 3 |
| IMDRF/MC/N37 FINAL:2015 | Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - PDF (53Kb) Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - DOCX (56Kb) | 2 October 2015 | 3 |
| IMDRF/MC/N38 FINAL:2015 | Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" - PDF (34kb) Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" - DOC (51kb) | 2 October 2015 | 3 |
| IMDRF/RPS WG/N26FINAL:2015 (Edition 2) | IMDRF Table of Contents (ToC) Pilot Plan - PDF (403Kb) IMDRF Table of Contents (ToC) Pilot Plan - DOCX (73Kb) | 8 July 2015 | 14 |
| IMDRF/MC/N25 FINAL:2015 | Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for human subjects – Good clinical practice" - PDF (59Kb) Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for human subjects – Good clinical practice" - DOCX (23Kb) | 7 April 2015 | 4 |
| IMDRF/Standards WG/N15FINAL:2014 | Standards WG: Final Report: 'List of international standards recognized by IMDRF management committee members' Current as of: March 2014 - PDF (200Kb) Standards WG: Final Report: 'List of international standards recognized by IMDRF management committee members' Current as of: March 2014 - DOCX (399Kb) Recognised standards - Australia - PDF (393kb) Recognised standards - Brazil - PDF (516kb) Recognised standards - Canada - PDF (420kb) Recognised standards - China - PDF (529kb) Recognised standards - Europe - PDF (402kb) Recognised standards - Japan - PDF (722kb) Recognised standards - Russia - PDF (611kb) Recognised standards - USA - PDF (581kb) | 21 November 2014 | 17 |
| IMDRF/MDSAP WG/N22FINAL:2014 | MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes - PDF (153Kb) MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes - DOCX (232Kb) | 18 September 2014 | 2 |
| IMDRF/RPS WG/N20FINAL:2014 | Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS - PDF (153Kb) Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS - DOCX (84Kb) Comment form for 'Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS' - XLSX (153Kb) | 30 June 2014 | 11 |
| IMDRF/RPS WG/N21FINAL:2014 | RPS Beta Testing Document - PDF (1.2Mb) | 16 May 2014 | 145 |
| Meeting number | Document title | Meeting date | Pages |
|---|---|---|---|
| 19 | Korea Virtual Meeting Outcome Statement - PDF (497kb) Korea Virtual Meeting Outcome Statement - DOCX (88kb) | 16-25 March 2021 | 3 |
| 18 | Singapore Virtual Meeting Outcome Statement - PDF (167kb) Singapore Virtual Meeting Outcome Statement - DOCX (84kb) | 25 September 2020 | 3 |
| 17 | Closed session management committee meeting outcome statement - PDF (507kb) Closed session management committee meeting outcome statement - DOC (114kb) | 18 March 2020 | 2 |
| 16 | Russia Yekaterinburg meeting outcome statement - PDF (139kb) Russia Yekaterinburg meeting outcome statement - DOCX (122kb) | 16-19 September 2019 | 3 |
| 15 | Moscow meeting outcome statement - PDF (143kb) Moscow meeting outcome statement - DOCX (75kb) | 18-21 March 2019 | 4 |
| 14 | China (Beijing) meeting outcome statement - PDF (125kb) China meeting outcome statement - DOCX (74kb) | 18-20 September 2018 | 3 |
| 13 | China meeting outcome statement - PDF (382kb) China meeting outcome statement - DOCX (75kb) | 20-22 March 2018 | 4 |
| 12 | Ottawa meeting outcome statement - PDF (41kb) Ottawa meeting outcome statement - DOCX (75kb) | 19-21 September 2017 | 3 |
| 11 | Vancouver meeting outcome statement - PDF (137kb) Vancouver meeting outcome statement - DOCX (74kb) | 14-16 March 2017 | 4 |
| 10 | Florianópolis meeting outcome statement - PDF (373kb) Florianópolis meeting outcome statement - DOCX (70kb) | 13-15 September 2016 | 4 |
| 9 | Brazil meeting outcome statement - PDF (92kb) Brazil meeting outcome statement - DOCX (70kb) | 8-10 March 2016 | 4 |
| 8 | Kyoto meeting outcome statement - PDF (52kb) Kyoto meeting outcome statement - DOCX (71kb) | 17 September 2015 | 4 |
| 7 | Tokyo meeting outcome statement - PDF (57kb) Tokyo meeting outcome statement - DOCX (70kb) | 26 March 2015 | 4 |
| 6 | Washington D.C meeting outcome statement - PDF (57kb) Washington D.C meeting outcome statement - DOCX (66kb) | 1 October 2014 | 4 |
| 5 | San Fransisco meeting outcome statement - PDF (33kb) San Fransisco meeting outcome statement - DOCX (64kb) | 27 March 2014 | 3 |
| 4 | Belgium meeting outcome statement - PDF (31kb) Belgium meeting outcome statement - DOC (76kb) | 12 November 2013 | 2 |
| 3 | France meeting outcome statement - PDF (60kb) France meeting outcome statement - DOC (159kb) | 19 March 2013 | 2 |
| - | IMDRF Chair and Secretariat rotates to Europe - PDF (35kb) IMDRF Chair and Secretariat rotates to Europe - DOCX (25kb) | 21 January 2013 | 1 |
| 2 | Sydney meeting outcome statement - PDF (63kb) Sydney meeting outcome statement - DOC (160kb) | 25 September 2012 | 2 |
| 1 | Singapore meeting outcome statement - PDF (56kb) Singapore meeting outcome statement - DOC (58kb) | 28 Feburary 2012 | 2 |
| - | Media statement - Successful Launch to the IMDRF - PDF (41kb) Media statement - Successful Launch to the IMDRF - DOC (29kb) | 28 March 2012 | 1 |
For a list of IMDRF meeting minutes and outcome statements, see the Meetings page.
For a list of IMDRF proposed documents, see the Consultations page.
GHTF final documents
These documents were created by the Global Harmonization Task force (GHTF). These are final documents and are still current. As the work of IMDRF progresses, these documents will be reviewed and published as IMDRF documents. Until that time, these documents are provided for the use of interested parties. If you become aware that any of these documents are out of date, please advise the IMDRF Secretariat so that a review can be scheduled on the IMDRF work plan.
To access archived GHTF documents, including meeting minutes, see the GHTF Archived Documents page.
- GHTF media releases
- GHTF Steering Committee
- GHTF Study Group 1 - Pre-market Evaluation
- GHTF Study Group 2 - Post-market Surveillance/Vigilance
- GHTF Study Group 3 - Quality Systems
- GHTF Study Group 4 - Auditing
- GHTF Study Group 5 - Clinical Safety/Performance
Https Www.parkland.edu Portals 3 Global Documents Catalog-pos Mathematics.pdf
Source: http://www.imdrf.org/documents/documents.asp
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